No
The summary describes a device that acquires and processes EEG signals to calculate a Bispectral Index (BIS). While this involves signal processing, there is no mention of AI, ML, or related concepts like neural networks, training sets, or performance metrics typically associated with AI/ML models. The performance studies focus on standard verification and validation testing against voluntary standards and a predicate device, not on the performance of an AI/ML algorithm.
No
The device is described as a monitor that acquires EEG signals and aids in monitoring the effects of anesthetic agents; it does not state that it provides therapy.
No
The device monitors the state of the brain by acquiring EEG signals and aiding in monitoring the effects of anesthetic agents. While it provides data, it is not described as being used to diagnose a medical condition or disease.
No
The device description explicitly states it is a "module" and a "component" of a host monitoring system, implying it is a physical piece of hardware that acquires EEG signals from sensors/electrodes. It does not function on its own and provides information to a bedside monitor for display, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BIS/EEG Module directly monitors the electrical activity of the brain (EEG signals) and processes this data to provide the Bispectral Index (BIS). This is a direct measurement of physiological activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states it monitors the state of the brain by data acquisition of EEG signals and aids in monitoring the effects of anesthetic agents. This is a real-time, in-vivo monitoring function.
Therefore, the BIS/EEG Module falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG Module is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS/EEG Module is intended to monitor the Bispectral Index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.
Product codes
OLW, OLT, ORT, OMC
Device Description
The BIS/EEG Module is part of a modular system used to monitor the state of the brain by data acquisition of EEG signals. The module is also used as an aid in monitoring the effects of certain anesthetic agents using Aspect's Bispectral Index® parameter.
BIS/EEG Module works as a component of a GE Medical Systems Information Technologies host monitoring system and does not function on its own. The BIS/EEG Module provides information obtained from the sensors/electrodes to the bedside monitor for display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG Module is intended for use on... patients within a hospital or medical facility providing patient care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The BIS/EEG Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the BIS/EEG Module:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- . Performance testing
- Safety testing .
- Environmental testing .
Conclusion:
The results of these measurements demonstrated that the BIS/EEG Module is as safe, as effective, and perform as well as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K974496, K923043 & K011843 Aspect Medical Systems, Inc. EEG Monitor with BIS Engine
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
OCT - 1 2001
K012466
102
Section 2 Summary and Certification
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | July 31, 2001 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Karen Webb |
| Sr. Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 382-3329 | |
| Fax: (414) 918-8114 | |
| Device: Trade Name: | BIS/EEG Module |
| Common/Usual Name: | Electroencephalograph (EEG) |
| Classification Names: | 21 CFR 882.1400 Electroencephalograph |
| Predicate Devices: | K974496, K923043 & K011843 Aspect Medical Systems, Inc. EEG |
| Monitor with BIS Engine | |
| Device Description: | The BIS/EEG Module is part of a modular system used to monitor the |
| state of the brain by data acquisition of EEG signals. The module is | |
| also used as an aid in monitoring the effects of certain anesthetic | |
| agents using Aspect's Bispectral Index® parameter. | |
| BIS/EEG Module works as a component of a GE Medical Systems | |
| Information Technologies host monitoring system and does not function | |
| on its own. The BIS/EEG Module provides information obtained from | |
| the sensors/electrodes to the bedside monitor for display. | |
| Intended Use: | The BIS/EEG Module is intended for use under the direct supervision of |
| a licensed healthcare practitioner or by personnel trained in its proper | |
| use. The BIS/EEG Module is intended for use on adult and pediatric | |
| patients within a hospital or medical facility providing patient care to | |
| monitor the state of the brain by data acquisition of EEG signals. | |
| The BIS/EEG Module is intended to monitor the Bispectral Index (BIS), | |
| a processed EEG variable which may be used as an aid in monitoring | |
| the effects of certain anesthetic agents. | |
| Technology: | The BIS/EEG Module employs the same functional scientific technology |
| as its predicate device. |
1
K012466
21F2
Test Summary:
The BIS/EEG Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the BIS/EEG Module:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews �
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- . Performance testing
- Safety testing .
- Environmental testing .
Conclusion:
The results of these measurements demonstrated that the BIS/EEG Module is as safe, as effective, and perform as well as the predicate device.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Karen Webb Senior Regulatory Affairs Specialist GE medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re: K012466
Trade/Device Name: BIS/EEG Module Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OLT, ORT, OMC Dated (Date on orig SE Itr): July 31, 2001 Received (Date on orig SE ltr): August 1, 2001
Dear Ms. Webb:
This letter corrects our substantially equivalent letter of October 1, 2001.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
APR - 9 2012
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
for
Sincerely vours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
K012466; 510(k) filed on July 31, 2001 510(k) Number (if known):
BIS/EEG Module Device Name:
Indications for Use:
The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare The BIS/ECG Module is microod in to proper use. The BIS/EEG Module is intended for use on precidents of by personner delitor in to pioper receivel facility providing patient cafe to monitor the state of the brain by data acquisition of EEG signals.
The BIS/EEG Module is intended to monitor the Bispectrail Index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
for Mark n Melleus
al. Restorative
510(k) Number K 012466